Clinical trials: PALB2 Gene Mutation
Pancreas Cancer, Peutz-Jeghers Syndrome (PJS)
The Cancer of the Pancreas Screening-5 CAPS5)Study
Johns Hopkins clinical research office quality assurance group will monitor and audit this study at Johns Hopkins. The Sub Investigator at each site will be responsible for internal monitoring at their site.
- Conditions
- Pancreas Cancer, Peutz-Jeghers Syndrome (PJS), Gene Mutation, Germline Mutation Carrier
- Trial name
- CAPS5 (NCT02000089)
- Testing
- Secretin, MRI, Tumor marker gene test with CA19-9
- Where
- 9 sites in United States
- Volunteers
- 9,000 people
- Sponsor
- Johns Hopkins University
Breast Cancer, PALB2-Mutated Breast Carcinoma
Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer
This research is being done to evaluate the safety and tolerability of the new drug, axatilimab, in combination with olaparib (a standard of care treatment) in Breast Cancer 1/2 genes (BRCA 1/2) and PALB2 associated HER2-negative…
- Conditions
- Breast Cancer, PALB2-Mutated Breast Carcinoma, HER2-negative Breast Cancer, BRCA1 Mutation
- Trial name
- NCT06488378
- Testing
- Axatilimab, Olaparib
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Dana-Farber Cancer Institute
Malignant Neoplasm of Breast, Breast Cancer
Comprehensive Analysis of Predictors of the Treatment With Pembrolizumab and Olaparib in Patients With Unresectable or Metastatic HER2 Negative Breast Cancer and a Deleterious Germline Mutation or a Homologous Recombination Deficiency (COMPRENDO
This study will examine the combination of pembrolizumab and olaparib in three populations. Cohort 1: aBC patients with a germline mutation in BRCA1 or BRCA2, cohort 2: aBC patients with a germline mutation in one of the moderate…
- Trial name
- COMPRENDO (NCT05033756)
- Testing
- Pembrolizumab Injection [Keytruda], Olaparib Oral Tablet [Lynparza]
- Where
- 6 sites in Germany
- Volunteers
- 11 people
- Sponsor
- Institut fuer Frauengesundheit
Pancreatic Acinar Cell Carcinoma, Pancreatic Adenosquamous Carcinoma
APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
This phase II trial investigates how well the addition of olaparib following completion of surgery and chemotherapy works in treating patients with pancreatic cancer that has been surgically removed (resected) and has a…
- Conditions
- Pancreatic Acinar Cell Carcinoma, Pancreatic Adenosquamous Carcinoma, Pancreatic Squamous Cell Carcinoma, Resectable Pancreatic Acinar Cell Carcinoma
- Trial name
- NCT04858334
- Testing
- Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging
- Where
- 456 sites in United States, Israel and 1 more
- Volunteers
- 152 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Prophylactic Irradiation to the Contralateral Breast for BCAs Patients
Breast cancer is the most common cancer in women worldwide, with high mortality. About 5% to 10% of breast cancers are hereditary.
- Trial name
- PICB (NCT04960839)
- Testing
- Prophylactic contralateral breast irradiation
- Where
- 8 sites in China, Singapore
- Volunteers
- 323 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Gene Mutation-Related Cancer, Genetic Predisposition
COsegregation of VARiants in Panel of Genes
The aim of the COVAR project is to achieve reliable classification of as many variants of interest as possible from the French OncoGenetics Database (FrOG, https://frog-db.fr/) in order to use them for the genetic counseling.
- Trial name
- COVAR (NCT01689584)
- Testing
- salivary kit
- Where
- 62 sites in France, Guadeloupe and 3 more
- Volunteers
- 11,000 people
- Sponsor
- Institut Curie
Advanced Breast Cancer, HER2/Neu Negative
Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors
The aim of this single-arm phase 2 clinical trial is to evaluate the anti-cancer activity of Talazoparib (also known as BMN 673) in patients with advanced breast cancer with specific genetic or tumor genomic alterations.
- Conditions
- Advanced Breast Cancer, HER2/Neu Negative, Triple-Negative Breast Cancer
- Trial name
- NCT02401347
- Testing
- Talazoparib Tosylate
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Melinda Telli
Advanced or Metastatic Solid Tumors, Breast Cancer
A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
The purpose of this study is to characterize the safety, tolerability, and efficacy of IDE161 as a single agent and in combination with pembrolizumab.
- Conditions
- Advanced or Metastatic Solid Tumors, Breast Cancer, Ovarian Cancer, Prostate Cancer
- Trial name
- NCT05787587
- Testing
- IDE-161, Pembrolizumab
- Where
- 27 sites in United States
- Volunteers
- 216 people
- Sponsor
- IDEAYA Biosciences
High Grade Serous Carcinoma, Triple Negative Breast Cancer
Combination of Olaparib and Navitoclax in Women with HGSC and TNBC
The purpose of this Phase I study is to determine if the PARP inhibitor olaparib can be safely combined with navitoclax, an inhibitor of Bcl-2/Bcl-XL, in women with TNBC who have somatic or germline mutations in breast cancer…
- Conditions
- High Grade Serous Carcinoma, Triple Negative Breast Cancer, Ovarian Cancer
- Trial name
- NCT05358639
- Testing
- Olaparib tablet, Navitoclax
- Where
- 3 sites in Canada
- Volunteers
- 36 people
- Sponsor
- Sunnybrook Health Sciences Centre
Tubo-ovarian Carcinoma, High-grade Serous Carcinoma
Risk-reducing Strategies, Including Fimbriectomy, in Women With a Germline Mutation Predisposing to Ovarian or Pelvic Cancer
FIMBRIMENOP-2402 study aims to evaluate the long-term management of cancer risks in premenopausal women who have a genetic predisposition to tubo-ovarian or primary peritoneal carcinoma, such as mutations in BRCA1, BRCA2, RAD51C…
- Conditions
- Tubo-ovarian Carcinoma, High-grade Serous Carcinoma, Primary Peritoneal Carcinoma Stage III, Primary Peritoneal Carcinoma Stage IV
- Trial name
- FIMBRIMENOP (NCT06726330)
- Testing
- Fimbriectomy Followed by Delayed Oophorectomy (F-DO), Bilateral Salpingo-Oophorectomy
- Where
- 23 sites in France
- Volunteers
- 1,100 people
- Sponsor
- Centre Oscar Lambret
Stage I Breast Cancer, Stage II Breast Cancer
Niraparib + Dostarlimab In BRCA Mutated Breast Cancer
This research study involves pre-operative therapy that is specifically targeted for breast cancer in individuals with BRCA and PALB2 mutations.
- Conditions
- Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, Breast Cancer
- Trial name
- NCT04584255
- Testing
- Niraparib, Dostarlimab
- Where
- 8 sites in United States
- Volunteers
- 66 people
- Sponsor
- Dana-Farber Cancer Institute
Metastatic Solid Tumor, BRCA1 Mutation
Combination Therapy in Cancers With Mutations in DNA Repair Genes
The purpose of this phase 1 clinical trials is to determine whether niraparib (a Poly (ADP-ribose) polymerase inhibitor (PARPi)) can be safely combined with irinotecan with manageable toxicity and reasonable efficacy.
- Conditions
- Metastatic Solid Tumor, BRCA1 Mutation, BRCA2 Mutation, ATM Gene Mutation
- Trial name
- NCT05694715
- Testing
- Niraparib, Irinotecan
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of California, San Francisco
Metastatic Breast Cancer, Invasive Breast Cancer
Olaparib In Metastatic Breast Cancer
This research study is for patients with metastatic breast cancer. Metastatic means that the cancer has spread beyond the breast.
- Conditions
- Metastatic Breast Cancer, Invasive Breast Cancer, Somatic Mutation Breast Cancer (BRCA1), Somatic Mutation Breast Cancer (BRCA2)
- Trial name
- NCT03344965
- Testing
- Olaparib
- Where
- 20 sites in United States
- Volunteers
- 114 people
- Sponsor
- Beth Israel Deaconess Medical Center
Prostate Cancer, BRCA Mutation
The GENPET Study - An Imaging Study of FCH-PET-CT in Men With Prostate Cancer and a DNA Repair Gene Mutation.
The aim of the study is to determine if PET-CT imaging (using contrast recommended in clinical guidelines) is superior to combined bone scan and MRI/CT of the abdomen \& pelvis in detecting the increased incidence of metastasis…
- Conditions
- Prostate Cancer, BRCA Mutation, Mismatch Repair Gene Mutation, ATM Gene Mutation
- Trial name
- GENPET (NCT05097274)
- Testing
- MRI pelvis or CT imaging under clinical management for Pr Ca, Whole body bone scan imaging, PET-CT imaging
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- Institute of Cancer Research, United Kingdom
Advanced Cancers
A Study of LY2606368 (Prexasertib) in Patients With Solid Tumors With Replicative Stress or Homologous Repair Deficiency
This research study is studying a checkpoint kinase 1 (CHK1) inhibitor as a possible treatment for advanced solid tumors that harbor genetic alterations in the homologous repair (HR) pathway, genetic alterations that indicate…
- Trial name
- NCT02873975
- Testing
- LY2606368
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Dana-Farber Cancer Institute
Pancreatic Cancer Metastatic
Vilastobart+Retifanlimab in BRCA or PALB2 Deficient PC
This is a single arm, open-label, non-randomized multi-institution phase II trial of a Fc enhanced CTLA4 antibody, vilastobart, in combination with PD-1 antibody, retifanlimab, in patients with BRCA1, BRCA2 or PALB2 deficient…
- Trial name
- EKLAVYA-HRD (NCT07765836)
- Testing
- vilastobart (XTX101), Retifanlimab
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Massachusetts General Hospital
Pancreatic Adenocarcinoma Metastatic, BRCA1 Mutation
SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells
The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer.
- Conditions
- Pancreatic Adenocarcinoma Metastatic, BRCA1 Mutation, BRCA2 Mutation, Pancreatic Acinar Cell Carcinoma
- Trial name
- SHARON (NCT04150042)
- Testing
- Melphalan, BCNU, Vitamin B12B
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- General Oncology, Inc.